U.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)
January 08, 2021 at 01:43 pm
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Applied DNA Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) published a safety communication (the “Communication”) that identifies the Company’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) as one of only two tests marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19. The identification of certain mutations can help identify samples that should be further characterized via genetic sequencing and can potentially assist with the early detection of new variants in patients, which may reduce further spread of infection. According to the Communication, the FDA monitors the potential effects of genetic variation on molecular tests that have received EUA, including the Company’s Assay Kit. The Communication notes that molecular tests designed to detect multiple SARS-CoV-2 genetic targets, such as the Assay Kit, are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. Based on analysis conducted by the Company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant. The Communication notes that the reduced sensitivity, also known as an S-gene dropout, may be indicative of certain SARS-CoV-2 mutations, including the B.1.1.7 variant. Due to the Assay Kit’s multi-target design, the Communication states the Assay Kit’s overall sensitivity should not be impacted.
Applied DNA Sciences, Inc. is a biotechnology company that develops, and markets deoxyribonucleic acid (DNA) based technology solutions. The Company is utilizing its LinearDNA large-scale polymerase chain reaction (PCR) based manufacturing platform. The Companyâs proprietary platform produces large quantities of DNA for use in the nucleic acid-based in vitro diagnostics and preclinical nucleic-acid based drug development and manufacturing markets and for supply chain security, anti-counterfeiting and anti-theft technology purposes. It also develops PCR-based molecular in vitro diagnostics for covid-19. In addition, under its wholly owned subsidiary, Applied DNA Clinical Labs, LLC, the Company is offering a high-throughput turnkey solution for population-scale Covid-19 testing marketed as safeCircle. safeCircle utilizes the Companyâs Covid-19 Diagnostic Tests and is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies.
U.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)
APPLIED DNA SCIENCES, INC. 
